HOSPIRA

Main information

  • Trade name:
  • HOSPIRA GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HOSPIRA GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220016
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220016

HOSPIRA GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution

for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

28/07/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. HOSPIRA GLYCOPYRROLATE INJECTION glycopyrronium bromide (glycopyrrolate) 0.2 mg/1 mL solution

for injection ampoule

Product Type

Single Medicine Product

Effective date

21/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

As a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions, and to reduce the acidity and volume of the gastric

contents. As a preoperative or intra-operative antimuscarinic to attenuate or prevent intra¯operative bradycardia associated with the use of

suxamethonium or due to cardiac vagal reflexes. To protect against the peripheral muscarinic actions (e.g. bradycardia and excessive secretions) of

anticholinesterases such as neostigmine or pyridostigmine given to reverse neuromuscular blockade produced by non-depolarising muscle relaxants.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

5 ampoules per pack

(S4) Prescription Only Medicine

Components

1. HOSPIRA GLYCOPYRROLATE INJECTION glycopyrrolate 0.2 mg/1 mL solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intramuscular

Intravenous

Visual Identification

Clear, colourless solution in a clear glass ampoule

Active Ingredients

glycopyrronium bromide (glycopyrrolate)

.2 mg/mL

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 03:03:27 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Page 1 of 3

Hospira™ Glycopyrrolate Injection

Hospira™ Glycopyrrolate Injection

Glycopyrronium bromide (glycopyrrolate)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Hospira™

Glycopyrrolate Injection. It does not

contain all of the available

information.

It does not take the place of talking to

your doctor or pharmacist.

All medicines have risks and benefits.

Your doctor has weighed the risks of

you taking Hospira™ Glycopyrrolate

Injection against the benefits they

expect it will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Hospira™

Glycopyrrolate

Injection is used for

Hospira™ Glycopyrrolate Injection

may be used;

before surgery to reduce the

amount of saliva produced by your

mouth, and other secretions

produced in your lungs and

stomach

before or during surgery to

maintain your heart’s normal

beating rhythm, or

it may also used to counter the

effects of some other medicines,

which can slow your heartbeat or

produce excessive secretions when

used during surgery.

This medicine belongs to a group of

medicines called “anticholinergics”

which work in the nervous system

to block an enzyme which is

responsible

for producing saliva in

your mouth, and secretions in your

stomach and lungs. This enzyme also

slows down the heart rate. When this

enzyme is blocked, secretions dry up

and the heart rate increases.

Your doctor may have prescribed

Hospira™ Glycopyrrolate Injection

for another purpose.

Ask your doctor if you have any

questions about why Hospira™

Glycopyrrolate Injection has been

prescribed for you.

Hospira™ Glycopyrrolate Injection

is not addictive.

This medicine is available only

with a doctor’s prescription.

Before you are given

Hospira™

Glycopyrrolate

Injection

When you must not be given

it

Do not have Hospira™

Glycopyrrolate Injection if you are

allergic to Hospira™ Glycopyrrolate

Injection or any of the ingredients

listed at the end of this leaflet.

Some of the symptoms of an allergic

reaction may include rash, itching,

hives on the skin, swelling of the face,

lips, tongue or other parts of the body,

shortness of breath, wheezing or

troubled breathing.

Do not have Hospira™

Glycopyrrolate Injection if the

packaging is torn or shows signs of

tampering.

Do not have Hospira™

Glycopyrrolate Injection after the

expiry date (EXP) printed on the

pack.

If you have it after the expiry date

has passed, it may not work as

well. The pharmacist will check

that the medicine is suitable for

use before you are given it.

Before you are given it

Tell your doctor if you have any

allergies to any other medicines,

any other substances, such as foods,

preservatives or dyes.

Tell your doctor if you are

pregnant or plan to become

pregnant, or if you are

breastfeeding or plan to

breastfeed.

Your doctor will discuss the risks

and benefits of receiving

Hospira™ Glycopyrrolate Injection

during pregnancy. It may also reduce

your milk supply. It is not known if

Hospira™ Glycopyrrolate Injection is

found in breast milk.

Tell your doctor if you have,

or have had, any other medical

conditions including:

asthma

glaucoma, ( increased pressure in

your eyes)

diarrhea or constipation

stomach or bowel problems

hiatus hernia

heart disease or high blood

pressure

hyperthyroidism

fever

myasthenia gravis (muscle

weakness)

kidney problems or difficulty

urinating

nerve or brain disorder, brain

damage

Down’s Syndrome.

If you have not told your doctor

about any of the above, tell them

before you are given Hospira™

Glycopyrrolate Injection.

Page 2 of 3

Hospira™ Glycopyrrolate Injection

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines may interfere with

Hospira™ Glycopyrrolate Injection.

These include:

ritodrine hydrochloride

belladonna alkaloids

medicines for Parkinson’s disease

antidepressants

phenothiazines, (used to treat

mental illness or severe nausea and

vomiting)

disopyramide

procainamide

quinidine

antihistamines

narcotic pain killers (pethidine,

thioxanthenes, butyrophenones or

amantadine)

digoxin (used to treat heart failure)

any corticosterlids

medicines used to control heart

rhythm

any other anticholinergic

medicines.

These medicines may be affected by

Hospira™ Glycopyrrolate Injection or

may affect how well it works. You

may need to take different amounts of

your medicine or you may need to

take different medicines.

Your doctor or pharmacist has more

information on medicines to be

careful with, or avoid, when given

Hospira™ Glycopyrrolate Injection.

How Hospira™

Glycopyrrolate

Injection is given

Follow all directions given to you by

your doctor or pharmacist

carefully.

They may differ from the information

contained in this leaflet.

If you do not understand the

instructions on the box/bottle, ask

your doctor or pharmacist for help.

How much is given

The dose of Hospira™ Glycopyrrolate

Injection may be different for each

person. The dose given will depend on

your condition, age and body weight.

The usual adult dose is 200 to 400

micrograms. Your doctor will decide

the right dose for you. For children

aged 1 month to 12 years, the usual

dose depends on their bodyweight.

How it is given

Hospira™ Glycopyrrolate Injection

will be given to you by injection

into either a vein or a muscle before

the anaesthetic.

How long is it given for

Hospira™ Glycopyrrolate Injection is

usually given as a single dose.

However, sometimes your doctor may

decide you need more. Your doctor

will decide how much Hospira™

Glycopyrrolate Injection you need.

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

13 11 26 for advice, or go to

Accident and Emergency at the

nearest hospital, if you think that

you or anyone else may have been

given too much Hospira™

Glycopyrrolate Injection. Do this

even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are having

Hospira™

Glycopyrrolate

Injection

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

have been given Hospira™

Glycopyrrolate Injection.

Tell any other doctors, dentists, and

pharmacists who treat you that you

have been given this medicine.

Always discuss with your doctor

any problems or difficulties during

or after having Hospira™

Glycopyrrolate Injection.

Things you must not do

Do not drive or operate machinery,

or perform hazardous work until

you know how Hospira™

Glycopyrrolate Injection affects

you.

Hospira™ Glycopyrrolate Injection

may cause drowsiness or blurred

vision in some people and therefore

may affect alertness.

Things to be careful of

Be careful if you are elderly, unwell

or taking other medicines

You may experience side effects such

as drowsiness or blurred vision, which

may increase the risk of a fall.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

Standing up slowly, especially when

you get up from bed or chairs, will

help your body get used to the change

in position and blood pressure. If this

problem continues or gets worse, talk

to your doctor.

Page 3 of 3

Hospira™ Glycopyrrolate Injection

Be careful during warm weather

and higher temperature, and/or

with physical exercise after use of

Hospira™ Glycopyrrolate Injection.

It may reduce your ability to sweat

and can therefore cause overheating.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well after having Hospira™

Glycopyrrolate Injection.

Hospira™ Glycopyrrolate Injection

may have unwanted side effects in

some people.

All medicines may have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical treatment if you

get some of the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

fast, slow or irregular heart beats

flushing skin, or inability to sweat

dry and/or itchy skin

feeling sick or vomiting

Nausea, vomiting

dry mouth, constipation

taste alterations, or loss of taste

difficulty urinating

impotence

blurred vision, other problems

with eyes

dizziness

seizures

insomnia (inability to sleep)

headache, nervousness, drowsiness

mental confusion in elderly

over-excitement in children

reduced milk supply in

breastfeeding women

headache

nervousness, drowsiness

fever or feeling hot

bloated feeling

muscular weakness or possibly

paralysis

injection site reactions like itchy

skin, swelling, pain.

These side effects are usually mild.

Tell your doctor immediately if you

notice any of the following:

rash, itching or hives on the skin,

swelling of the face, lips, tongue or

other parts of the body, shortness

of breath, wheezing or trouble

breathing

cold sweat, nausea, light

headedness, discomfort in chest or

other areas of the upper body like

pain or discomfort in one or both

arms, the back, neck, jaw or

stomach

muscular weakness or possibly

paralysis.

These are serious side effects. You

may need urgent medical attention.

Serious side effects are rare.

Other side effects not listed above

may occur in some patients.

Tell your doctor if you notice

anything else that is making you

feel unwell.

Ask your doctor or pharmacist if

you don’t understand anything

in this list.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

After having

Hospira™

Glycopyrrolate

Injection

Storage

Hospira™ Glycopyrrolate Injection

will be stored in the pharmacy or on

the ward. The injection is kept in a

cool dry place, stored below 25

Disposal

The hospital staff will dispose of any

leftover product.

Product description

What it looks like

Hospira™ Glycopyrrolate Injection

comes as a clear, colourless solution

in a clear glass ampoule.

Ingredients

Each ampoule of Hospira™

Glycopyrrolate Injection contains

glycopyrronium bromide

(glycopyrrolate) as the active

ingredient.

Each 1 mL ampoule contains 200

micrograms of glycopyrronium

bromide (glycopyrrolate). It also

contains:

Water for Injections

Sodium Chloride and

Hydrochloric acid

Hospira™ Glycopyrrolate Injection

does not contain lactose, sucrose,

gluten, tartrazine or any other azo

dyes.

Sponsor

Hospira™ Glycopyrrolate

Injection is supplied by:

Australia:

Pfizer Australia Pty Ltd

ABN 50 008 422 348

38-42 Wharf Road

WEST RYDE NSW 2114

Toll Free Number:

1800 675 229

Hospira™ Glycopyrrolate Injection is

available in the following strengths:

200 micrograms/mL

AUST R 220016

This leaflet was prepared

March 2017.

13-7-2018

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira Issues Voluntary Nationwide Recall of Daptomycin for Injection Lyophilized Powder for Solution, Due to Infusion Reactions

Hospira, Inc., a Pfizer company, is voluntarily recalling 8 lots of Hospira’s Daptomycin for Injection 500 mg, Lyophilized Powder For Solution, Single Dose Vial (NDC 0409-0106-01) to the Hospital/Retail level. The product is being recalled due to adverse event reports indicative of infusion reactions.

FDA - U.S. Food and Drug Administration

4-6-2018

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira Issues a Voluntary Nationwide Recall for Two Lots of Naloxone Hydrochloride Injection, USP, in the Carpuject™ Syringe System due to the Potential Presence of Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling lots 72680LL and 76510LL of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system (NDC 0409-1782-69), to the hospital/institution level due to the potential presence of embedded and loose particulate matter on the syringe plunger.

FDA - U.S. Food and Drug Administration

4-6-2018

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System   by Hospira: Recall - Due to the Potential Presence of Particulate Matter

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter

The patient has a low likelihood of experiencing adverse events ranging from local irritation, allergic reactions, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, pulmonary dysfunction, pulmonary infarction, and toxicity.

FDA - U.S. Food and Drug Administration

1-11-2018

Taxespira (Hospira UK Limited)

Taxespira (Hospira UK Limited)

Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

8-10-2018

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6606 of Mon, 08 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4069/T/04

Europe -DG Health and Food Safety

24-9-2018

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

Europe -DG Health and Food Safety

7-8-2018

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (AstraZeneca AB)

Duaklir Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5419 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

7-8-2018

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (AstraZeneca AB)

Brimica Genuair (Active substance: aclidinium bromide / formoterol fumarate dihydrate) - Centralised - Yearly update - Commission Decision (2018)5420 of Tue, 07 Aug 2018

Europe -DG Health and Food Safety

11-7-2018

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Novartis Europharm Limited)

Seebri Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4513 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2430/T/27

Europe -DG Health and Food Safety

11-7-2018

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Novartis Europharm Limited)

Tovanor Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4526 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2690/T/30

Europe -DG Health and Food Safety

4-7-2018

Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Novartis Europharm Limited)

Enurev Breezhaler (Active substance: glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4342 of Wed, 04 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2691/T/27

Europe -DG Health and Food Safety

14-6-2018

Incruse (Glaxo Group Ltd)

Incruse (Glaxo Group Ltd)

Incruse (Active substance: umeclidinium bromide) - Centralised - Yearly update - Commission Decision (2018)3855 of Thu, 14 Jun 2018

Europe -DG Health and Food Safety

24-5-2018

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Novartis Europharm Limited)

Ultibro Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3259 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2679/R/24

Europe -DG Health and Food Safety

24-5-2018

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Novartis Europharm Limited)

Xoterna Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Renewal - Commission Decision (2018)3265 of Thu, 24 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3755/R/27

Europe -DG Health and Food Safety

16-5-2018

Inflectra (Hospira UK Limited)

Inflectra (Hospira UK Limited)

Inflectra (Active substance: Infliximab) - Centralised - Yearly update - Commission Decision (2018)3054 of Wed, 16 May 2018

Europe -DG Health and Food Safety

15-5-2018

Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Novartis Europharm Limited)

Ulunar Breezhaler (Active substance: indacaterol/glycopyrronium bromide) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3058 of Tue, 15 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3875/T/24

Europe -DG Health and Food Safety

15-5-2018

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Hospira UK Limited)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Yearly update - Commission Decision (2018)3059 of Tue, 15 May 2018

Europe -DG Health and Food Safety

2-5-2018

Trydonis (Chiesi Farmaceutici S.p.A.)

Trydonis (Chiesi Farmaceutici S.p.A.)

Trydonis (Active substance: beclometasone / formoterol / glycopyrronium bromide) - Centralised - Authorisation - Commission Decision (2018)2713 of Wed, 02 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4702

Europe -DG Health and Food Safety

26-4-2018

Riarify (Chiesi Farmaceutici S.p.A.)

Riarify (Chiesi Farmaceutici S.p.A.)

Riarify (Active substance: beclometasone / formoterol / glycopyrronium bromide) - New authorisation - Commission Decision (2018)2581 of Thu, 26 Apr 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4836

Europe -DG Health and Food Safety